Case Studies

After more than five years of litigation, on April 26, 2016, a three-judge Superior Court panel in Pennsylvania upheld the denial of a motion for certification of a class action against Epstein Becker Green clients Keystone Mercy and AmeriHealth Caritas Health Plans.

In December 2010, the plaintiff, on behalf of his daughter, filed a lawsuit against the two insurers, claiming that they violated state consumer protection laws by losing a flash drive containing the personal health information (PHI) of more than 283,000 individuals and by failing to live up to their promise to protect and safeguard these individuals’ PHI.

In denying the plaintiff’s class certification motion, the panel found that the trial court had “carefully considered the numerosity, typicality, adequacy of representation, and fair and efficient method of adjudication requirements for class certification under Rule 1702 [('Prerequisites to a Class Action')] and found the class action requirements were not met.” In addition, the panel agreed with the trial court’s ruling that the plaintiff could not properly represent potential class members because he was unable to conclusively link his daughter to the PHI contained on the lost flash drive. Also, the panel left in place the trial court’s finding that, as there was no there was no actual harm associated with the data breach, the plaintiff failed to fulfill the typicality requirements for a class action.

On February 2, 2010, Epstein Becker Green attorneys successfully executed a very favorable settlement for their client, AtriCure Inc., in a False Claims Act (FCA) case that began with a qui tam relator's charges filed in 2007. AtriCure is a developer and manufacturer of cardiac surgical ablation devices.

This case presented sophisticated claims relating to alleged improper off-label promotion. This is an issue that has become a high priority for Department of Justice enforcement of which both drug and device manufacturers and distributors should be aware.

The settlement, based on an ability-to-pay methodology accepted by the government, requires AtriCure to pay total of $3.8 million, plus interest, periodically over five years; resolves issues of potential FCA and common law violations relating to the marketing practices of AtriCure's surgical ablation devices; and includes AtriCure's declaration that the company and its employees haven't engaged in any wrongdoing or illegal activity. The settlement agreement has been approved and resolves a related qui tam matter, which Epstein Becker Green attorneys have been handling, regarding AtriCure's marketing of the devices. (Epstein Becker Green also represents AtriCure in a related and ongoing private securities class action.) Additionally, AtriCure signed a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

The Epstein Becker Green team that represented AtriCure was led by Stuart M. Gerson, a leading litigator and national authority on the FCA.

Attorneys from the Antitrust Counseling and Defense practice at Epstein Becker Green (“EBG”) recently coordinated with the Federal Trade Commission (“FTC”) to help an industry client block anti-competitive state board regulations.The client,a holding company that operates dental service practices, opposed regulations proposed by the Texas State Board of Dental Examiners that would have restricted dentists’ ability to contract with dental service organizations (“DSOs”) and ultimately hamper business competition.

The Texas board, largely composed of individual practitioners appointed by the governor of Texas, attempted to promulgate several regulations that would have imposed new restrictions on a dentist’s ability to enter into arrangements with DSOs for administrative and non-clinical services. This threat engendered a massive DSO industry response, as the regulatory effort imperiled the operations of scores of interstate businesses. EBG was among a number of law firms, lobbying firms, and public relations firms that were commissioned to thwart the effort.

While the Texas board’s proposals were in contention, the Supreme Court of the United States was hearing arguments in a very similar case brought by the FTC against the North Carolina State Board of Dental Examiners. The FTC alleges that the North Carolina board’s exclusive regulation is an anticompetitive effort that violates federal antitrust laws.

Noting this, the Antitrust Counseling and Defense practice at EBG consulted regularly with North Carolina counsel and the FTC and successfully prompted the FTC to make a submission in the Texas rulemaking proceeding, condemning the proposed regulations there. FTC staff, in response to a notice requesting public comments, urged the Texas board to reject two proposed rules that impose new restrictions on the ability of Texas dentists to enter into contracts with non-dentists, including DSOs, for the provision of nonclinical, administrative services.

The FTC comment, submitted by staff of the FTC’s Office of Policy Planning, Bureau of Competition, and Bureau of Economics, on October 6, 2014, stated that the rules (proposed 22 Tex. Admin. Code § 108.70 and § 108.74) seemed likely to discourage dentists from affiliating with DSOs by mandating that dentists assume responsibility for the types of functions that DSOs typically provide and by expanding the Texas board’s authority to take disciplinary action against dentists who enter into these prohibited agreements. By contrast, under the current regulations, such service agreements for many business functions—such as accounting and bookkeeping—are presumed not to violate the Texas Dental Practice Act. The comment explains that such restrictions may reduce competition, likely resulting in higher prices and reduced access to dental services, especially for underserved populations. The FTC’s comment is part of ongoing efforts to promote competition in the health care sector, which benefits consumers through lower costs, better care, and more innovation. As the FTC stated:

We have consistently maintained that the choice of business model is an important dimension of the competitive process that should not be restricted by regulation or private agreement but based on reliable evidence that regulation is reasonably necessary to achieve an important public purpose.

On November 21, 2014, the Texas board withdrew the regulatory proposals. EBG’s leadership position in this effort ultimately saved the day for its clients and others in the DSO industry.

Epstein Becker Green (EBG), serving as health regulatory counsel, successfully assisted its client Becton, Dickinson and Company (BD), a medical technology company, in conducting health regulatory due diligence and negotiating the terms of a purchase agreement to be used in connection with the client’s acquisition of CareFusion Corporation, an international medical products manufacturer. The purchase price was valued at $12.2 billion. This deal will substantially expand BD’s geographic reach and catalog of medical devices, enabling BD to become a world leader in medication management and patient safety solutions. BD announced the signing of the purchase agreement on October 5, 2014, and the transaction is expected to close during the first half of 2015.

EBG attorneys Bradley Merrill Thompson and Kim Tyrrell-Knott led a team that conducted the preliminary due diligence on various health regulatory issues, particularly U.S. Food and Drug Administration (FDA) and privacy and security matters. As CareFusion is operating under a consent decree from FDA, an examination of the FDA regulatory issues and assessment of CareFusion’s FDA quality system were key components of the due diligence and critical to the transaction going forward. The EBG team, working alongside transactional counsel, negotiated health regulatory terms and advised on health regulatory issues associated with the value drivers for the deal and post-closing integration plans.

Epstein Becker Green represented Fallon Health in connection with the sale of its subsidiary, Home Staff, to Associated Home Care, an affiliate of Amedisys, for an undisclosed amount. Home Staff provides nonmedical home care and private duty services through home health aides who do not hold professional licenses. Amedisys, one of the nation’s leading home health care and hospice companies, is looking to the Home Staff acquisition to enhance Amedisys’s presence and staffing capabilities in the Massachusetts area.

Epstein Becker Green advised Fallon Health over a fairly lengthy period—stretching from the auction process to closing—on a wide ranges of issues, including the definitive purchase agreement, governance matters, and the execution of the closing itself.